Study and Monitoring of Early Undifferentiated Arthritis

NCT03666091 | Completed DMC

• 1 other identifier: P030717
• Study Type: observational
• Target: 813
• Locations: 0 countries
• Sites: N/A

Brief Summary

The French Society of Rheumatology initiated a large national multicenter, longitudinal and prospective cohort, ESPOIR, in order to set up databases to allow various investigations on diagnosis, prognostic markers, epidemiology, pathogenesis and medico-economic factors in the field of early arthritis and rheumatoid arthritis. The primary objective is to set-up a multicentre cohort of early arthritis (less than 6 months) in France that could serve as a database to studies of various natures. Specific objectives are in the following domains:

• diagnosis: to help determine among clinical, biological, radiographic and immunogenetics those parameters allowing for the earliest diagnosis classification as possible, in order to target early therapy;
• prognosis: to identify early those patients at risk of severe disease by investigating among clinical, biological, genetic and sociologic factors;
• medico-economic: to identify the costs and their determinants at various disease stage;
• pathologic: to collect a databank of sera, DNA, RNA to allow for studies of transcriptomes and other genomics. Secondary objectives are twofold:
• to monitor adverse events, particularly rare drug adverse events, in collaboration with other international studies
• to allow access to the data collected in this cohort study in order to facilitate new projects submitted to and approved by the scientific committee.

Conditions

Early Rheumatoid Arthritis or Early Undiffentiated Arthritis

Keywords

ESPOIR cohort RA Early Undifferentiated Arthritis

Outcome Measures

Primary Outcomes (8)

• Remaining in the cohort.

  Presence of the patient at the visit.

  20 years

• Prescription of synthetic or biologic disease-modifying antirheumatic drugs (DMARD).

  Number of patients treated or not.

  20 years

• Patient disability evaluation.

  Evaluation by Health Assessment Questionnaire Disability Index (HAQ-DI). The following categories are assessed by the HAQ-DI: dressing and grooming, arising, eating, walking, hygiene, reach, grip, common daily activities. The patients report the amount of difficulty they have in performing some of these activities. Each question asks on a scale ranging from 0 to 3. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment.

  20 years

• Change in Disease Activity (levels of activity or remission)

  1. Disease Activity Score (DAS28). The DAS28 provides an absolute indication of RA disease activity on a scale of 0.49 to 9.07 A DAS28 value \>5.1 corresponds to a high disease activity, A DAS28 value between 3.2 and 5.1 corresponds to a moderate disease activity, A DAS28 value between 2.6 and 3.2 corresponds to a low disease activity, A DAS28 value \< 2.6 corresponds to remission. 2. Physician and patient activity VAS. Scales from 0 to 100. A high value indicates extreme activity.

  20 years

• Quality of life assessed by EQ-5D-3L/ EUROQOL

  The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The EQ VAS records the respondent's self-rated health (0-100).

  20 years

• Quality of life assessed by MOS-SF-36/ MOS 36-Item Short-Form Health Survey

  MOS-SF-36/ MOS 36-Item Short-Form Health Survey contains 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides the perceived change in health. Each dimension has a scale (0-100). Low score=poor quality of life.

  15 years (from baseline to 15 years)

• Quality of life assessed by AIMS2-SF/Arthritis Impact Measurement Scales 2 Short Form

  AIMS2-SF/Arthritis Impact Measurement Scales 2 Short Form contains 26 items : upper-extremity functioning, lower-extremity functioning, affect, symptoms, social interaction, and role. Scores are summed and converted to a range of 0-10. Higher scores=poorer health.

  14 years (from baseline to 14 years)

• Radiographic damage evaluation

  Structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components.The SHS method evaluates, in each hand, 16 areas for erosions and 15 areas for JSN, and, in each foot, 6 areas for erosions and 6 areas for JSN. The erosion score per hand joint can range from 0 to 5. JSN and joint subluxation or luxation are combined in a single score, from 0 to 4. The maximal score for erosion and JSN are 160 and 120, respectively, for the hands and 120 and 48, respectively, for the feet. The maximal total SHS is 448.

  20 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 814 patients with early arthritis were included be- tween November 2002 and april 2005.One patient removed his consent form. All the centres were active and each regional centre recruited between 35 and 83 patients.

You may qualify if:

• patients aged over 18 and under 70
• clinical diagnosis of rheumatoid arthritis as certain or probable
• clinical diagnosis of undifferentiated arthritis potentially becoming rheumatoid arthritis
• at least 2 inflammatory joints since 6 weeks : a swollen joint has to be observed in two articular sites and be present since at least 6 weeks
• arthritis starting since less than 6 months

You may not qualify if:

• patients aged less than 18 years or aged more than 70 years
• pregnant women
• undifferentiated rheumatism with no potential chance to become rheumatoid arthritis
• other inflammatory rheumatisms clearly defined

Sponsors & Collaborators

• Societe Francaise de Rhumatologie: lead
• Amiens University Hospital: collaborator
• University Hospital, Bordeaux: collaborator
• University Hospital, Brest: collaborator
• University Hospital, Lille: collaborator
• University Hospital, Montpellier: collaborator
• Saint Antoine University Hospital: collaborator
• Pitié-Salpêtrière Hospital: collaborator
• Hôpital Cochin: collaborator
• Bicetre Hospital: collaborator
• Bichat Hospital: collaborator
• University Hospital, Rouen: collaborator
• University Hospital, Strasbourg, France: collaborator
• University Hospital, Toulouse: collaborator
• University Hospital, Tours: collaborator

Related Publications (6)

• Vittecoq O, Guillou C, Hardouin J, Gerard B, Berenbaum F, Constantin A, Rincheval N, Combe B, Lequerre T, Cosette P. Validation in the ESPOIR cohort of vitamin K-dependent protein S (PROS) as a potential biomarker capable of predicting response to the methotrexate/etanercept combination. Arthritis Res Ther. 2022 Mar 21;24(1):72. doi: 10.1186/s13075-022-02762-5.

  PMID: 35313956 DERIVED

• Kumaradev S, Roux C, Sellam J, Perrot S, Pham T, Dugravot A, Molto A. Socio-demographic determinants in the evolution of pain in inflammatory rheumatic diseases: results from ESPOIR and DESIR cohorts. Rheumatology (Oxford). 2022 Apr 11;61(4):1496-1509. doi: 10.1093/rheumatology/keab562.

  PMID: 34270700 DERIVED

• Roubille C, Coffy A, Rincheval N, Dougados M, Flipo RM, Daures JP, Combe B. Ten-year analysis of the risk of severe outcomes related to low-dose glucocorticoids in early rheumatoid arthritis. Rheumatology (Oxford). 2021 Aug 2;60(8):3738-3746. doi: 10.1093/rheumatology/keaa850.

  PMID: 33320245 DERIVED

• Valdeyron C, Soubrier M, Pereira B, Constantin A, Morel J, Gaudin P, Combe B, Gremeau AS, Dejou-Bouillet L, Pouly JL, Sapin V, Oris C, Brugnon F. Impact of disease activity and treatments on ovarian reserve in patients with rheumatoid arthritis in the ESPOIR cohort. Rheumatology (Oxford). 2021 Apr 6;60(4):1863-1870. doi: 10.1093/rheumatology/keaa535.

  PMID: 33147613 DERIVED

• Mouterde G, Gamon E, Rincheval N, Lukas C, Seror R, Berenbaum F, Dupuy AM, Daien C, Daures JP, Combe B. Association Between Vitamin D Deficiency and Disease Activity, Disability, and Radiographic Progression in Early Rheumatoid Arthritis: The ESPOIR Cohort. J Rheumatol. 2020 Nov 1;47(11):1624-1628. doi: 10.3899/jrheum.190795. Epub 2019 Dec 15.

  PMID: 31839594 DERIVED

• Lukas C, Mary J, Debandt M, Daien C, Morel J, Cantagrel A, Fautrel B, Combe B. Predictors of good response to conventional synthetic DMARDs in early seronegative rheumatoid arthritis: data from the ESPOIR cohort. Arthritis Res Ther. 2019 Nov 15;21(1):243. doi: 10.1186/s13075-019-2020-x.

  PMID: 31730497 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum at baseline, 6, 12, 18, 24, 36, 60, 120, 180 and 240 months / Urine at baseline, 24 and 36 months / DNA

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bernard COMBE, MD, PHD

  Montpellier University Hospital rheumatology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 11, 2018
• Study Start: November 13, 2002
• Primary Completion: April 19, 2005
• Study Completion: July 13, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-07